ADVANCE MPI 2: Study of Regadenoson Versus Adenoscan® in Patients Undergoing Myocardial Perfusion Imaging (MPI)

Sponsor

Gilead Sciences (Industry)

Overall Status

Completed

CT.gov ID

NCT00208312

Collaborator

Astellas Pharma US, Inc. (Industry)

787

Enrollment

Location

Arms

Duration (Months)

56.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Adenoscan® (adenosine) is an approved pharmacological stress agent indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately. The investigational drug, regadenoson (CVT-3146) is a selective A2A adenosine receptor agonist, the receptor responsible for coronary vasodilation, and is being studied for potential use as a pharmacologic stress agent in myocardial perfusion imaging (MPI) studies. This study will compare the safety and efficacy of regadenoson to that of Adenoscan in detecting reversible myocardial perfusion defects.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Drug: Regadenoson Drug: Adenosine	Phase 3

Detailed Description

ADVANCE MPI 2 is a multi-national, double-blind, randomized, active-controlled, parallel group clinical trial to evaluate the safety and efficacy of regadenoson in SPECT MPI compared to that of the approved pharmacological stress agent, Adenoscan. Patients referred for a clinically indicated pharmacological stress MPI study will be eligible for enrollment. The trial is designed: (1) to compare the pharmacological stress SPECT images obtained with regadenoson to those obtained with Adenoscan, and (2) to compare the safety and tolerability of the two stress agents.

Study Design

Study Type:

Interventional

Actual Enrollment :

787 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

A Phase III, Randomized, Double-Blind Study of Intravenous CVT-3146 Versus Adenoscan® in Patients Undergoing Stress Myocardial Perfusion Imaging

Study Start Date :

Apr 1, 2004

Actual Primary Completion Date :

Jun 1, 2005

Actual Study Completion Date :

Jun 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Regadenoson	Drug: Regadenoson 0.4 mg, bolus intravenous injection Other Names: Lexiscan CVT-3146
Active Comparator: 2 Adenoscan	Drug: Adenosine 0.14 mg/kg/min for 6 minutes, intravenous infusion Other Names: Adenoscan

Arm

Intervention/Treatment

Experimental: 1

Regadenoson

Drug: Regadenoson

0.4 mg, bolus intravenous injection

Other Names:

Lexiscan

CVT-3146

Active Comparator: 2

Adenoscan

Drug: Adenosine

0.14 mg/kg/min for 6 minutes, intravenous infusion

Other Names:

Adenoscan

Outcome Measures

Primary Outcome Measures

Non-inferiority of regadenoson to Adenoscan for use in SPECT myocardial perfusion imaging in assessing reversible perfusion defects [After radiopharmaceutical administration]

Secondary Outcome Measures

Safety and tolerability comparison of regadenoson to Adenoscan [Up to two weeks]
Additional comparisons of images obtained with regadenoson to those obtained with Adenoscan [After radiopharmaceutical administration]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Referred for a clinically indicated pharmacological stress SPECT myocardial perfusion imaging study

Exclusion Criteria:

Any condition precluding the safe administration of Adenoscan for a SPECT myocardial perfusion imaging study
Pregnant or breast-feeding, or (if pre-menopausal), not practicing acceptable method of birth control